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RecruitingNCT05146180PARAVAUpdated Jan 2, 2026

Interest of Parametric Positron Emission Imaging in the Diagnosis of Infections on Cardiac Valve Prosthesis

An interventional study of Parametric positron emission computed tomography in Endocarditis, sponsored by Centre Henri Becquerel. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-02.

Sponsored by Centre Henri Becquerel · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Feb 2022; still recruiting 4 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The objective of this study is to determine if early parametric positron emission computed tomography is useful to diagnose cardiac prosthetic valve infections.

Read the detailed description

In addition to routine examinations (biological and microbiological tests, transesophageal or transthoracic ultrasound, transesophageal or transthoracic ultrasound, and leukocyte scintigraphy) of a parametric acquisition during the positron emission computed tomography parametric acquisition during positron emission computed tomography , this examination being itself planned in a standard way.

The definitive diagnosis according to the Duke-Li criteria will be established three months later in a multidisciplinary consultation meeting.

The final diagnosis according to the Duke-Li criteria will be made three months later in a multidisciplinary consultation meeting, blinded to the results of the parametric positron emission computed tomography, and with knowledge of the results of the standard positron emission computed tomography and the entire work-up.

Results and all the complementary work-up.

02

Conditions studied

  • Endocarditis

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03

In context

Endocarditis

173 studies on the registry are indexed under Endocarditis; 57 are open to participants now.

This study's planned enrollment of 30 is below the median of 92 across 86 interventional studies indexed under Endocarditis.

Browse Endocarditis studies →

Lead sponsor

Centre Henri Becquerel is the lead sponsor of 59 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age superior to18 years,
  • Effective for women of childbearing age or negative pregnancy test on the day of the exam
  • Good general condition. WHO ≤ 1
  • Suspicion of endocarditis on a prosthetic heart valve implanted more than 3 months ago
  • Labeled polynuclear scintigraphy performed within a maximum of 15 days before positron emission computed tomography
  • Standard positron emission computed tomography planned as part of the extension assessment
  • Informed and signed consent before any specific study procedure.
  • Patient affiliated to the social security system

Exclusion criteria

Exclusion Criteria:

  • Presence of an active cancer in the previous three years
  • Pregnancy or breastfeeding
  • Poorly controlled diabetic patients
  • Protected adults (under guardians or curators)
  • Impossible decubitus (orthopnea, ...),
  • to FDG or to one of the of the radiopharmaceutical.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Parametric positron emission computed tomography

    Device: Parametric positron emission computed tomography

Interventions

  • DeviceParametric positron emission computed tomography

    Patients will undergo parametric positron emission computed tomography in 15 days after the labeled polynuclear scintigraphy

06

What researchers measure

Primary outcomes

  1. Determination of diagnostic value of parametric positron emission computed tomography

    area under the curve of the Ki parameter (and the Vd parameter) as a function of the presence of endocarditis diagnosed during the multidisciplinary consultation meeting at 3 months

    Time frame: 3 months

Secondary outcomes

  1. Correlation between parametric positron emission computed tomography and scintigraphy with labelled leukocytes

    comparison between diagnosis established by parametric positron emission computed tomography and scintigraphy with labelled leukocytes

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05146180
Lead sponsor
Centre Henri Becquerel
Responsible party
Sponsor
First posted
Dec 6, 2021
Start date
Feb 24, 2022
Primary completion
Dec 1, 2026 (estimated)
Completion
Mar 1, 2027 (estimated)
Last update
Jan 2, 2026

Study contacts

Mathieu Chastan, MD
Contact
mathieu.chastan@chb.unicancer.fr
+33276673032
Doriane Richard, PhD
Contact
doriane.richard@chb.unicancer.fr
+33232082985
Mathieu Chastan, MD
principal investigator · Centre Henri Becquerel

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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